Archive for the ‘Pmarmaceuticals’ Category

500,000 doses are distributed annuallySanofi Pasteur is the sole manufacturer of the only FDA approved yellow fever vaccine YF-VAX in the US. 500,000 doses are distributed annually, one third to the US military are two thirds to the civilian clinics. In November, 2015 the vaccine supply was impacted when Sanofi Pasteur began the process of moving manufacturing of the vaccine to a new facility. A large number of vaccines were lost in a production problem therefore diminishing the supply. Although efforts were made by Sanofi Pasteur to extend the supply by rationing the doses left, the CDC was not notified of the issue and imminent depletion of supplies until spring of 2016.

Sanofi Pasteur does manufacture another yellow fever vaccine that is used widely around the world, Stamaril. Special approval as an investigational new drug (IND) was obtained from the FDA to be allow supply and administration of Stamaril in the US. Stamaril and the YF-VAX are comparable in efficacy and risk of side effects therefore seen as interchangeable. Usually, roughly 4,000 sites in the US administer YF-VAX, while only 250 have been chosen to be allowed to supply Stamaril.

Currently there is no policy in place to address vaccine production in a vaccine shortage situation, and this must be addressed in further regulation and policy.

This vaccine shortage is not the first nor unfortunately the last that will take place. With this in mind, a policy addressing vaccine production issues has to be put forth. This should include a notification process allowing enough time for enacting a contingency plan to boost supply through alternate production and possible rationing. A national policy that outlines the procedure of notifying the CDC of possible shortages along with penalties to the company if not followed is imperative to lessen the impact of a shortage or to prevent it altogether. A new component of the FDA vaccine approval process and annual inspection should be added as well requiring an action plan to produce vaccines in case of a failure of supply or of production transfer in cases of withdrawal of the company from the market. It is unacceptable that one manufacturer’s difficulty, mistake, or withdrawal from the market impacts the health of the entire nation when this could be prevented with planning and coordination.

The Florida Department of Health, along with Gov. Rick Scott, should negotiate cancer treatment costs at quality cancer centers in Florida, such as Moffitt Cancer Center, and with pharmaceutical companies like Bristol-Myers Squibb to reduce out-of-pocket expenses for Medicare beneficiaries. The Florida Department of Health should place caps on cancer treatment costs to maintain them at reasonable prices. This political action would test whether cancer treatment cost negotiations at the state level are more effective than federal level negotiations. Biomedical companies can flexibly negotiate cancer treatment prices based on prevalences and morbidities in distinct states.

Besides other factors that affect cancer treatment like transportation costs, psychosocial stressors, and reduced quality of life, add stress to a patient’s cancer care experience despite the financial resources provided by organizations like the American Cancer Society.

Opioids contribute to the 142 people that die each day in America of drug overdose. The President has claimed that he plans to declare a state of emergency, an unprecedented move, typically reserved for natural disasters and disease outbreaks that are more acute in nature, which has the potential to unleash access to beneficial solutions such as addiction treatment.

There are 2 ways to declare a state of emergency: via the Stafford Act, which is typically reserved for natural disasters like hurricanes and tornadoes, and the Public Health Service Act, which is focused on medical issues. Both would unlock resources for proposed solutions – the former focused on law enforcement and measures further limiting access while the latter, coming from the secretary of health and human services, focused more on comprehensive medical measures. Please choose carefully.

The CDC breaks that number down. More than half of overdose deaths involve opioids, either prescription opioids or heroin. Overall rates of overdose have dramatically increased between 2000 and 2014. However, death rate increases since 2010 have been driven by heroin while rates from prescription opioids have plateaued or decreased, indicating that recent policy focused on blocking access may be simply shifting the small proportion that actually become addicts toward a more dangerous, means of getting high.

Few treatment options exist for people that live with chronic, severe pain. The nation needs non-opioid medicines that are effective at relieving severe pain, but that are safe and not potentially abusive. Until then, adequate management is complex and requires a balance of pharmacological and non-pharmacological approaches, which requires provider education and provider time with patients.

Further exacerbating the issue, prescribers and pharmacist, fearful of litigation and criminalization, withhold prescription opioids from those that legitimately need it. Inadequate pain management impacts not only quality of life, but deteriorates activities of daily living and leads to depression, anxiety, and “self-medication” with more harmful substances such as alcohol.

Despite often erroneously interchanged, there is a distinction between physical dependenceand addiction– perhaps the single most important nuance to understand when managing pain and deciding on policy that impacts people with pain. Chronic pain, by definition, does not go away, but the opioid receptors in the brain develop a tolerance, eventually diminishing the pain-relieving effects of opioids at their current dose. This is dependence, and it is normal. Doses need to be incrementally increased over time to provide the same level of relief. Those with very long-standing pain may need very high doses. Policy that is focused on restricting access to high doses seems to not take this into consideration.

U.S. Department of Health and Human Services strategies for combating the opioid crisis

A decision that emphasizes walled boarders and law enforcement will likely not be effective at reducing overdose and may actually worsen the issue of access further for an often silent, but suffering multitude that are not getting the care that exists, but is increasingly not within their reach. We need policy that pushes people to life-saving measures such as comprehensive pain management, access to addiction treatment without fear or stigma, provider education, and research to enhance our understanding of pain and addiction.

However, progress has been slow. The Healthy Newborn Network tracks the status of chlorhexidine implementation worldwide. Many countries with the highest neonatal mortality rates (>30 deaths/1,000 live births) still remain in the “pilot/policy alignment”, “expressed interest”, and “no information” categories. Nepal started implementing its chlorhexidine program in 2011, and Madagascar in 2013. Nigeria and Afghanistan following suit only last year. Who is missing? The top three countries with the highest neonatal mortality: Angola, Pakistan, and Central African Republic.

At 50 cents per dose, and in a gel form that is straightforward to apply to the umbilical cord, it begs the question why chlorhexidine has not been implemented more widely. Certainly, there are challenges, such as “regulatory hurdles, supply issues, and misconceptions about guidelines for umbilical cord care”, but these are not insurmountable. The slow roll-out has consequences, given that chlorhexidine has the potential to save 422,000 lives over a five-year period.

It is time the world got its act together, and for Angola, as the worst-offending country, to demonstrate its leadership and tackle its mark of shame. We call on the Angolan Ministry of Health to work with international agencies such as WHO, USAID, and PATH to rapidly introduce and scale chlorhexidine disinfection across the country.

A new strategy targets drug manufacturers: California Assemblyman Kevin McCarty proposed an amendment to AB 1512 which would enact taxes of $0.01/mg upon the sale of opioid ingredients from manufacturer to wholesaler. Funds collected would then be placed within the bill’s newly created Opioid Prevention and Rehabilitation Program Fund, and distributed to rehabilitation and addiction programs. As physicians and active community members, we strongly support AB 1512.

The bill was amended in the California Assembly on May 9, 2017, is currently in its second hearing within the committee, and its tax-collection component requires 66% approval in both the Senate and Assembly. However, because the proposed tax affects multinational corporations’ financial health and might negatively impact jobs, significant opposition exists against this legislation.

One vocal opponent to AB 1512 is the California Chamber of Commerce (CalChamber). CalChamber remains the largest organization advocating on behalf of businesses and maintains that AB 1512 is “unfair,” likely to “reduce the workforce” and “increase drug prices for ill patients who need these medications the most.”

In addition to supporting AB 1512, we call on CalChamber to reconsider its negative position and instead influence its constituents to support the legislation. CalChamber’s argument fails to recognize negative externalities and high costs that businesses currently absorb with the opioid epidemic unchecked. CalChamber must recognize that increased opioid pain prescriptions and resultant fatal and non-fatal overdoses lead to overutilization of hospitals and emergency rooms, directly contribute to rising healthcare costs. Moreover, opioids serve as gateway drugs to illicit substances such as heroin, spilling into local communities, further consuming emergency, police, and public and private resources.

Roles of HPV vaccines

Human papillomavirus (HPV) causes more than 99 percent of cervical cancer. Persistent infection with certain types of HPV can lead to specific cancer such as cervix, anus, vagina, vulva, penis, mouth, or sinuses. In Japan, HPV infection leads to cervical cancer in about 10,000 women every year and 2,700 women die of cervical cancer every year. World Health Organization (WHO) recommends HPV vaccines in adolescents more than 9 years of age to prevent infection with types of HPV known to cause cervical cancer. It is clear that these vaccines significantly reduce the number of women who develop cervical pre-cancer. It is estimated that mortality rate of cervical cancer could be reduced by 70 to 80% if they are available diffusely on targeted population throughout the nation.

It was concerned that risk of HPV type 16/18 infection at the age of 20 would noticeably increased among girls born between 2000 and 2003 compared to other age groups (Fig A). This negative effect was estimated to be worse if resuming encouragement was extended until 2020. However, MHLW has not changed their policy yet in 2017 although the Japan Society of Obstetrics and Gynecology released statement of resumption of HPV vaccines encouragement.

Anaphylaxis is the severe and sudden onset of an allergic reaction triggered by allergies to a specific food, medication, insect bite/sting and/or latex. According to a press release by The Asthmas and Allergy foundation of America (AAFA), anaphylaxis is estimated to occur 1 in 50 Americans although it may be higher at 1 in 20. AAFA found many of these at risk individuals were not prepared to react to a reaction episode, due to the lack of ownership of an epinephrine auto-injector pen. Reasons for lack of ownership were not cited however in the past year attention has been drawn to its cost. Mylan, the #1 producer of the over the past 10 years, with their patented epinephrine auto-injector delivery system, the Epipen.

The Business Insider performed a cost analysis of the Epipen, citing a market price increase from $100 in 2007 to $600 in 2016. Mylan’s has had few competitors. Their main competitor was Auvi-Q by Kaleo until its recall in 2015. One competitor still exists on the market today, Adrenaclick by amedra pharmaceuticals with a price tag of approximately $200 with a good prescription coupon.

The FDA has made it easier for Mylan to hike up their prices by limiting manufacturer competition through the recall or blockage of other epinephrine auto-injector devices as well as the back log for generic drugs that has been occurring producing a delay of competitors entering the market. Such politics granted Mylan the ability to increase their prices astronomically however in this past summer they received extreme backlash from two major stakeholders. Congress asked Mylan CEO to justify Epipen price hikes and the dropping of the Epipen coverage by Cigna, a major insurance company. This pushback motivated Mylan to create a generic version of this drug delivery system as well as patient coupons (up to $300) in coverage of Epipen costs to address concerns about its price. These are steps in the right direction however there needs to be more action to keep advocate for whose healthcare coverage still does not grant them the ability to pay $300 or less in out-of-pocket expenses.

I challenge the FDA to uphold their mission to protect the public’s health by ensuring safety, efficacy and security of human drugs and medical devices while accelerating innovation to make medical products more effective, safer and more affordable. The FDA must amend their current policies and procedures to promote the presence of competitors for safe and effective epinephrine auto-injector pens to eradicate the monopoly. This can be done through the overhaul of the generic drug backlog to funnel competitors into the market as well as looking for additional ways for those without adequate health insurance coverage to more affordable epinephrine auto-injector pens and discounts. I challenge competitors to propose refillable epinephrine auto-injector pens, like Dr. Cathleen London in Maine, to provide patients with an feasible alternative. A refillable pen will drastically cut down on the burden of cost for those American citizens whose lives depend on the ownership and access to epinephrine auto-injector pens in case of an anaphylactic shock episode.

Antimicrobial resistance (AMR) can arise from inappropriate use of antimicrobial medications (AMMs). In the United States, more than 80% of all AMMs are used in food animal production, including classes of medications that are on the WHO list of critically important AMMs. Prior to 2017, many AMMs for food animal production could be purchased and used without a prescription and for purposes such as “growth promotion,” rather than for treating a documented infection.

In 2012 and 2013, the FDA released Guidance for Industry, which sought to define judicious use of AMMs in food production, as well as to recommend that the animal pharmaceutical industry voluntarily change their labeling of critically important AMMs used in food production. In short, the FDA recommended that certain AMMs should no longer be used without veterinary oversight or solely for “growth promotion.” Using these medications against their labelled purposes would then constitute a violation of the Federal Food, Drug, and Cosmetic Act.

Despite pushback from industry groups such as the National Pork Producers Council and the National Turkey Federation, which argue that there is no firm science supporting the concept that AMMs in animal production result in AMR in humans, the FDA has shown some early successes of their new guidelines. According to reports published this year, the pharmaceutical industry voluntarily either changed all new drug applications to require veterinary oversight or withdrew the applications from consideration by January 2017. Credit: wellnesswarrior.org

However, there is more work to be done. Further guidance from the FDA should tighten controls on the use of AMMs in food production for disease prevention purposes. Currently, use of AMMs for disease prevention can includeprophylactic administration of subtherapeutic doses for prolonged periods, dosed imprecisely in feed or water, to entire herds or flocks. Additionally, organizations focused on veterinary medicine and animal care, such as the USDA, should be made part of the Transatlantic Task Force on Antimicrobial Resistance (TATFAR). Finally, improved animal husbandry in food production facilities (decreased crowding, improved sanitation) would lead to less infectious disease.

By refusing to amend the Illicit Drug Anti-Proliferation Act, Congress continues to stand in the way of harm-reduction services as the number of drug-related deaths continues to mount in the night life and music communities.

What is the Illicit Drug Anti-Proliferation Act?

In 2003, the Illicit Drug Anti-Proliferation Act (Read the full text here.) was passed by Congress in an effort to combat deaths due to ‘club’ drugs, such as MDMA. This act states that organizers of an event where controlled substances are suspected to be present can be charged with a felony for contributing to drug use, punishable by up to 20 years imprisonment, a fine of up to $500,000, and can have their venue seized by law enforcement.

Past Month Ecstasy Use among People Aged 12 or Older, by Age Group: Percentages, 2002-2014. Figure produced by 2014 Drug Use report sponsored by HHS

One victim of this act was 19 year-old Shelly Goldsmith, a student at the University of Virginia, who died of dehydration and heatstroke after consuming MDMA at a rave in Washington D.C. Shelley collapsed while attempting to make her way through the hot, crowded venue to the bar to buy a bottle of water. The current act discourages venues from distributing free water to prevent heat stroke or any other harm-reduction services, else they face federal prosecution for suspicion of contributing to drug use.

Shelley Goldsmith died at 19 years old from heatstroke after ingesting MDMA at an Electronic Dance Music concert where no free water was available, is seen here posing with Vice President Joe Biden, who authored the Anti Illicit Drug Proliferation Act

Advocates such as Shelley’s mother, Dede Goldsmith, have spoken to Congress on the importance of harm reduction and educating the public on safe drug use. Senator Tim Kaine has recently announced that he intends to propose an amendment to current law which will allow venues to provide harm-reduction services without bearing the risk of legal consequences.

Unfortunately, the bill is unlikely to easily pass. Most members of Congress are nervous about appearing ‘soft’ on drug policies and will need to be shown that harm-reduction is the will of the people and that passing this amendment will save lives.

Donate! The organization, ATRA (AmendTheRaveAct.org) creates and distributes campaign materials to educate the public on the harms caused by this amendment

Speak out! By explaining the benefit of harm reduction, and the differences between harm-reduction and the promotion of drug use, you can help turn the tide of public opinion against using an abstinence only strategy to reduce drug related-deaths.